Abbott

Manager Quality Assurance

Abbott • $99K — $198K *
Temecula, CA 92592In-Person
Healthcare
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent experience required
  • 6+ years in healthcare, medical device, or biotechnology
  • Medical Device experience highly preferred
  • Experience in quality system environments
  • Ability to develop and utilize new work processes

Responsibilities

  • Lead and develop the quality assurance team
  • Monitor and guide daily operations of staff
  • Ensure compliance with FDA and other regulatory standards
  • Manage complaint handling processes from start to finish
  • Coordinate regulatory reporting activities for medical devices
  • Develop and present strategies to regulatory agencies
  • Act as a consultant on regulatory issues within the division

Benefits

  • Comprehensive health and wellness benefits
  • Support for career development and employee training
  • Encouragement of continuous improvement across the department
  • Engagement in regulatory strategy initiatives
  • Flexibility to participate in industry change feedback
Full Job Description
JOB DESCRIPTION:

Job Title

Quality Assurance Manager

The Opportunity

We are seeking a Quality Assurance Manager for Abbott Vascular in our Temecula, CA site. This is an onsite role.

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Job Summary

This position provides leadership and guidance for the department, has responsibility for recruiting, developing and retaining talented employees, supports company goals and objectives, and communicates key information to staff members and senior management.

What You'll Work On:
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, MedDev, DOH regulations etc).
  • Notifies appropriate personnel for possible litigation and aids and responds to requests for information related to litigation concerns.
  • Monitors complete complaint handling process from first contact through closure of file and notifies appropriate personnel of issues that prevent a smooth flow.
  • Maintains personnel records and where appropriate develops work schedules for departments customer complaint hotline to ensure no customers are transferred to v-mail during business hours.
  • Develop strategies for regulatory reporting of medical devices.
  • Coordinate MDR, Vig, MHLW, reporting activities for a variety of device regulatory requirements including: US post market studies, IDE exemptions, international regulatory reporting and annual summaries.
  • Develop and deliver presentations to global regulatory agencies and other business units.
  • Topics may include MDR position strategies, compliance issues or new initiatives such as Global Harmonization.
  • Coordinate Division comments on proposed regulations.
  • Represent Division in industry feedback for changes in regulatory law.
  • Serve as internal consultant on regulatory issues such as regulatory processes, interpretation of regulatory laws or review of proposed regulatory position changes.
  • Participate in department systems development initiatives, which may include complaint database development.


Required Qualifications
  • Minimum of a Bachelor's degree An equivalent combination of education and work experience

Experience
  • Minimum of 6 years of experience within the healthcare, medical device, or biotechnology industry.
  • Medical Device experience highly preferred
  • Monitors progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility.
  • Will perform this job in a quality system environment.
  • Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit.


Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

The base pay for this position is
$99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
AVD Vascular

LOCATION:
United States > Temecula : Building E - TE

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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